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Ben Goldacre is now on a North American tour promoting his book, Bad Pharma, his expose of the pharmaceutical industry. On the book’s overleaf, he has the following quote:

“The tricks and distortions documented in these pages are beautiful, intricate, and fascinating in their details.”

Actually, the same can be said for examples that Goldacre uses to make various points in his book. Goldacre has major concerns about the need for more transparency when it comes to making data from clinical trials publicly available. In fact, he spends about one-third of Bad Pharma discussing this topic. I agree that one of the big challenges that the industry faces is the need to be more transparent about its work and I have written about this both on this blog and in Devalued & Distrusted. However, Goldacre’s cherry-picking of data to fit his arguments is inappropriate and infuriating to those who know something about the pharmaceutical industry.

Right at the outset of Bad Pharma, Goldacre tells the story of TGN1412. This is a horrific tale of six young males who, in 2006, volunteered for a phase 1 study for a novel drug, TGN1412. Phase 1 is the very first step in the study of a new drug in people. It is simply meant to test the drug, initially at very low doses, to see how well tolerated it is. TNG1412 was an antibody designed to stimulate the immune system and, in doing so, fight cancer in a whole new way. The hope for TGN1412 was to have it used to treat a rare form of leukemia.

Unfortunately, the volunteers in this phase 1 trial suffered immediate and severe side-effects. These men experienced an immunological firestorm in that the antibody caused the uncontrolled release of toxins. As a result, the volunteers suffered severe adverse events starting with rapid blood pressure lowering, then respiratory issues, kidney failure, etc. Fortunately, thanks to extraordinary efforts by excellent doctors in London Hospitals, all survived.

Goldacre’s purpose in telling this story is that he feels this episode could have been prevented in two ways. First, since this is an unprecedented experimental treatment, the drug should have not been given to six volunteers simultaneously, but rather in a staggered process. He is correct on this. Had this been done, only one volunteer would have been endangered. But his second concern is a real stretch. He believes that a study done ten years earlier by an academic researcher on a single subject could have foretold the events with TGN1412. Unfortunately, this result was never published. Goldacre uses this example to support his argument that pharma selectively publishes data and, in doing so, harms patients.

Here is what Goldacre does NOT tell you about TGN1412.

1) TGN1412 was being developed, not by a pharma company, but by TeGenero, a biotech company with 15 employees that was formed based on work done at the University of Wurzburg. TeGenero, a 15 person company, was not exactly a big pharma.

2) This was known to be a controversial area of research as people were worried that toying with the immune system could have dire consequences. Thus, experts in the field urged caution. The risks were well understood without the need of knowing about a single experiment 10 years earlier. My guess is that some experts would not agree that this isolated incident was truly relevant to the TNG1412 case.

“It is certainly possible to change the way in which novel agents are tested to minimize the number of subjects who are put at risk. As long as we continue to manipulate biology in new ways, we probably cannot prevent all such events from occurring. We must do what we can to minimize risk, but the future health of the world population demands that we not let adverse events put an end to medical progress. We must treat those at risk with respect and great care, but the work must go on.” Dr. Jeffrey M. Drazen

Given this additional background, it is hard to see why Goldacre uses this example to support his arguments. Perhaps it to use sentences like: “Their fingers and toes went flushed, then brown, then black, and then began to rot and die.” That should certainly raise the ire of the general public. Unfortunately, this case is being used for sensationalism and not to advance the cause that Bad Pharma claims to espouse.